USDA, Food Safety and Inspection Service, ASD, PCS, Room 2163 South Building, 1400 Independence Avenue SW, Washington, DC 20250-3700

66 -- RAPID DIAGNOSTIC TEST FOR THE DETECTION OF ESCHERICHIA COLI 0157:H7 SOL FSIS-60-W-97 DUE 082597 POC Contact Point, Julie Adams, (202) 720-9891 The Food Safety and Inspection Service (FSIS) is requesting information on any commercially available and collaboratively studied rapid diagnostic test designed specifically for the detection of all viable Escherichia coli O157:H7. This information should include all package inserts, any publications relative to the product and any peer reviewed evaluation data. Emphasis should be placed on the use of this product to analyze meat and poultry products. In order for a product to be considered for FSIS evaluation, it must meet or exceed the following performance characteristics: Sensitivity >= 98%; Specificity >= 90%; False Negative rate <=2%; and False Positive rate <= 10%. Preference will be given to a 96-well format enzyme-linked immunosorbent assay (ELISA) test which can be run on automated equipment. The performance criteria given above must be met by running the ELISA test on automated equipment. The manufacturer must submit these performance criteria as part of the supporting material for this submission. Details of the 96-well automated ELISA equipment currently used by FSIS will be provided upon request. Preference will be given to an AOAC collaboratively trialled method approved as an AOAC Official Method of the AOAC INTERNATIONAL. It should be noted that detection of the organism will subsequently require cultural recovery and confirmation. In addition to the above test performance criteria derived on 96-well automated ELISA equipment, manufacturers must fully answer the following: (1) Elapsed time between start of sample analysis and generation of test results. (2) Potential biological hazards created by the test method. (3) Total hands-on technical time required by the test method. (4) Cost of the test. All submissions must be sent to the Contracting Office at the above address by August 25, 1997. Only those submissions sent to the Contracting Office will be accepted. The Agency will review all submissions and select up to three products which best meet the criteria described above. FSIS will provide each of the three offers identical sets of 100 ground beef samples for analysis by the rapid diagnostic test method run on automated ELISA equipment. Offerors will be asked to submit the results of all sample analyses to FSIS for further consideration. All information supplied will become the property of FSIS. This information is for planning purposes only and does not constitute an Invitation for Bid or a Request for Proposals, nor does it promise that any procurement will follow. THERE IS NO SOLICITATION DOCUMENT AVAILABLE. (0218)

Loren Data Corp. http://www.ld.com (SYN# 0421 19970808\66-0013.SOL)